The primary objective of this study is to assess the effectiveness of myo-inositol supplementation to prevent pregnancy complications in women with PCOS. Secondary objectives are to evaluate the impact of supplementation on maternal (mental) and…
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
- Pregnancy, labour, delivery and postpartum conditions
- Gonadotrophin and sex hormone changes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint will be the incidence of the composite outcome of either
gestational diabetes mellitus, and/or preeclampsia and/or preterm birth (i.e.
birth before 37 weeks gestational age).
Secondary outcome
Secondary endpoints will include indicators of maternal physical and mental
well-being, maternal health-related quality of life, neonatal outcomes,
breastfeeding practices and breastmilk composition. In addition, a full
cost-effectiveness analysis will be performed.
Background summary
Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder in women
of reproductive age. PCOS is a heterogeneous condition, characterised by
metabolic disturbances, insulin resistance and hyperandrogenism. Pregnancies in
women with PCOS have an increased risk of gestational diabetes mellitus,
preeclampsia and preterm birth, and their offspring have an increased risk of
aberrant birth weight and hospitalization. After pregnancy, PCOS is thought to
have an impact on breastfeeding success and breastmilk composition.
Current strategies to improve pregnancy outcome among women with PCOS have not
demonstrated significant risk reduction. Myo-inositol is a commonly used
dietary supplement with a favourable effect on glucose metabolism and insulin
sensitivity. Optimal intake of myo-inositol is associated with a decrease in
glucose, lower insulin and lower testosterone levels in women with PCOS. Among
women with PCOS-related disorders (e.g. in women with obesity), myo-inositol
supplementation in pregnancy has been shown to have clinical benefits in
preventing adverse pregnancy outcomes in a number of clinical trials, by
reducing the risk of gestational diabetes mellitus, hypertensive complications
and preterm birth. However, there are currently no prospective trials to
evaluate the effect of myo-inositol supplementation as a nutritional
intervention to prevent pregnancy complications among women with PCOS.
Study objective
The primary objective of this study is to assess the effectiveness of
myo-inositol supplementation to prevent pregnancy complications in women with
PCOS. Secondary objectives are to evaluate the impact of supplementation on
maternal (mental) and neonatal health and assess cost-effectiveness.
Study design
Prospective multicentre, double-blind, randomised controlled trial.
Intervention
Participants randomly allocated to the intervention group will receive 4 grams
myo-inositol added to their routinely recommended folic acid supplement,
divided over two daily sachets of sugary powder throughout pregnancy. The
control group will receive similar looking sachets of supplements containing
only the standard dose of folic acid without the added myo-inositol supplement
as part of the current standard-of-care recommendation.
Study burden and risks
Myo-inositol supplements have been used in several previous trials in pregnancy
and is considered a safe food supplement without any side effects or risks.
Myo-inositol is well tolerated at the amounts used in this study. In addition
to receiving supplements, participants will be asked to complete three
questionnaires, provide blood and urine samples once each trimester of
pregnancy, and routine ultrasound scanning will be performed to assess fetal
growth. All study visits will be aligned with routine antenatal care
appointments and blood tests. Additionally, subjects can choose to participate
in research on the impact of myo-inositol supplementation on breastfeeding and
take part in the MYPP Biobank. The results of this study will provide important
novel recommendations for PCOS patients on the importance of optimising
life-style and nutrient intake to prevent pregnancy complications.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Inclusion criteria
- >= 18 years of age
- Diagnosis of PCOS according to the Rotterdam consensus criteria and confirmed
by a gynaecologist
- A viable singleton pregnancy confirmed by ultrasound
- Being able to initiate the use of study supplements between 8+0 and 16+0
weeks gestational age
- Ability to understand Dutch or English
- Ability to provide written informed consent
Exclusion criteria
- Diagnosis of pre-existent type-1 or 2 diabetes mellitus
- Pre-existent renal failure, defined as an estimated glomerular filtration
rate (eGFR) less than 50 ml/min/1.73m2
- Use of myo-inositol supplements, other insulin-mimetics, hypoglycaemic agents
(e.g. metformin) and/or systemic steroids, that cannot be discontinued at the
time of inclusion
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67329.078.18 |
| Other | NL7799 |